Doctor Accused of Taking Kickbacks to Prescribe Anti-Psychotic Drug

Nov. 15--A federal lawsuit accuses a Chicago psychiatrist of
getting illegal kickbacks from pharmaceutical companies and
submitting at least 140,000 false claims to Medicare and Medicaid
for anti-psychotic medications he prescribed for thousands of
mentally ill patients in nursing homes.

Dr. Michael J. Reinstein also submitted at least 50,000 claims
to Medicare and Medicaid falsely claiming he had provided
"pharmacologic management" for his patients at more than 30 area
nursing homes and long-term care facilities, according to the
health care fraud lawsuit filed by the U.S. attorney’s
office.

"This is the largest civil case alleging prescription medication
fraud against an individual ever brought in Chicago," said Acting
U.S. Attorney Gary S. Shapiro.

Reinstein was the subject of an investigation by ProPublica and
the Chicago Tribune in 2009 that found Reinstein, 69, had compiled
a worrisome record of providing assembly-line care with a highly
risky drug.

Searching publicly available documents, reporters discovered
that Reinstein had been accused of overmedicating his mentally ill
patients. His unusually heavy reliance on the drug clozapine -- a
potent psychotropic medication that carries five "black box"
warnings -- has been linked to at least three deaths.

In 2007 he prescribed various medications to 4,141 Medicaid
patients, including more prescriptions for clozapine than were
written by all the doctors in Texas put together, Medicaid records
show. Records also showed he was getting government reimbursement
for seeing an improbably large number of patients.

Reinstein has provided psychiatric medical services in the
Chicago area since 1973. Since at least 1999, he has maintained an
office in the Uptown neighborhood, which prosecutors said has the
densest concentration of mentally ill nursing home residents in
Illinois.

According to the federal lawsuit, Reinstein routinely prescribed
anti-psychotic and other psychiatric medications to his patients
based, not on their need but on his receipt of kickbacks from
pharmaceutical companies.

Reinstein routinely prescribed Clozaril, the trade name for
clozapine manufactured by Novartis, and he often had more than
1,000 patients using the medication at any given time, the lawsuit
state. For many years, Novartis paid Reinstein to promote Clozaril,
it alleges.

After Novartis’ patent for Clozaril expired in 1998,
Reinstein resisted pharmacy and drug company efforts to switch his
patients to generic clozapine and he continued to be the largest
prescriber of Clozaril to Medicaid recipients in the United States,
the lawsuit states.

In July 2003, Novartis notified Reinstein that it would be
withdrawing its support for Clozaril, and ended the regular
payments that it had been making to Reinstein.

In August 2003, the lawsuit says Reinstein offered to switch his
patients to generic clozapine manufactured by Ivax Pharmaceuticals
if the company met several conditions: Agree to pay Reinstein
$50,000 under a one-year "consulting agreement"; pay his nurse to
speak on behalf of clozapine; and fund a clozapine research study
by a Reinstein-affiliated entity known as Uptown Research
Institute.

Ivax agreed and Reinstein immediately began switching his
patients from Clozaril to Ivax’s clozapine, according to the
lawsuit, which noted that he "quickly became the largest prescriber
of generic clozapine in the country."

"Reinstein’s inordinate prescribing of clozapine stands in
stark contrast to its extremely limited use by other physicians,"
the lawsuit stated.

The suit noted that, generally, 4 percent of schizophrenia
patients who were prescribed antipsychotics received clozapine. But
during the time Reinstein was allegedly accepting kickbacks from
Ivax, more than 50 percent of his patients were prescribed
Ivax’s clozapine, it charged.

At one nursing home, Reinstein had 75 percent of the 400
residents on Ivax’s clozapine.

In January 2006, Ivax became a subsidiary of Teva
Pharmaceuticals Industries. From 2007 to 2009, the suit alleges,
Teva and Reinstein entered into annual "speaker agreements" that
resulted in Teva paying Reinstein more than $100,000.

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